Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.
We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.
For the expansion of our team, argenx is looking for a Senior Medical Writer who will provide medical writing support for developing complex clinical, nonclinical, and safety documents for regulatory submissions.
This individual will execute the overall strategy for all medical writing processes according to argenx medical writing standards and corporate objectives.
Author and project manage SME contribution to develop content for regulatory submissions that is well-organized, consistent, accurate, and compliant with argenx Medical Writing standards, including style guide, lexicon, templates, and libraries
Authors content for phase 1-4 protocols, master ICFs, IBs, and CSRs
Responsible for inspection-readiness of medical writing activities
Supports the lead writer and project teams to ensure project deadlines are met
Executes corporate objectives, goals, measures, and strategies
Capable of working on multiple deliverables simultaneously
Bachelor’s degree in a scientific or clinical discipline or related field is required; Ph.D. preferred
Minimum of 3 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
Native/bilingual or fluent American English proficiency
Experience with Veeva Vault and Please Review
Experience with implementing lean writing techniques
Basic understanding of scientific methodology as applied to drug development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
Familiarity with pharmacovigilance guidelines and developing aggregate reports
Ability to work precisely according to procedures and regulations
Ability to prioritize and multi-task successfully in a fast-paced environment
Ability to work autonomously, as well as in a team
Excellent written and verbal communication skills
Excellent time management skills and a proven ability to work on multiple projects at any given time
At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com.
If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.
Originally posted on Himalayas
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